Comparison of Efficacy of Cefotaxime, Ceftriaxone, and Ciprofloxacin for the Treatment of Spontaneous Bacterial Peritonitis in Patients With Liver Cirrhosis
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Korea University
- Enrollment
- 261
- Locations
- 2
- Primary Endpoint
- Infection resolution rates within 5 days of treatment
Study Overview
Brief Summary
Spontaneous bacterial peritonitis (SBP) is one of the most serious complications of liver cirrhosis. Mainstay of treatment for SBP is use of proper antibiotics. Although, several antibiotics including cefotaxime, ceftriaxone, or ciprofloxacin are being used, it is unclear which drug is most effective. Our aim of study is to compare the efficacy of the three current antibiotics for the treatment of SBP in patients with liver cirrhosis.
The primary hypothesis is that the efficacy of all the antibiotics will not significantly different. This is non-inferiority trial.
Detailed Description
Spontaneous bacterial peritonitis (SBP) is one of the most serious complications of liver cirrhosis. Mainstay of treatment for SBP is use of proper antibiotics. Although, several antibiotics including cefotaxime, ceftriaxone, or ciprofloxacin are being used, it is unclear which drug is most effective. Our aim of study is to compare the efficacy of the three current antibiotics for the treatment of SBP in patients with liver cirrhosis.
The primary hypothesis is that the efficacy of all the antibiotics will not significantly different. The expected success rates (infection resolution rates) are 83%, 87%, and 78% for cefotaxime, ceftriaxone, and ciprofloxacin. This is non-inferiority trial. The level of significance is 5%. The power of this stuy is 80%. Non-inferiority margin is 15%. Therefore 87 patients for each group are needed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Liver cirrhosis patients with ascites
- •Ascitic fluid PMN cell count >250/mm3
- •Age: 16~70 years old
Exclusion Criteria
- •Allergic to 3rd generation cephalosporin or quinolone
- •Antibiotics within 2 weeks
- •Open abdominal surgery within 4 weeks
- •Evidence of 2ndary peritonitis, intrabdominal hemorrhage, pancreatitis, Tb peritonitis, or peritoneal carcinomatosis
- •HCC with portal vein thrombosis
- •Pregnant woman
- •HIV positive
Arms & Interventions
Cefotaxime
iv 2G q 8hrs for general, dose titration if needed (eg.CKD)
Intervention: Cefotaxime (Drug)
Ceftriaxone
iv 2G q 24hrs
Intervention: Ceftriaxone (Drug)
Ciprofloxacine
iv 400mg q 12hrs for general, dose titration if needed (eg.CKD)
Intervention: Ciprofloxacin (Drug)
Outcomes
Primary Outcomes
Infection resolution rates within 5 days of treatment
Time Frame: 5 days (120 hours)
PMN \< 250/mm3 from ascitic fluid
Secondary Outcomes
- Mortality & recurrence rates within 1 month(1 month)
Investigators
Soon Ho Um
Professor
Korea University